Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-40...
FDA Device Recall #Z-1060-2015 - Class II, December 23, 2014
Recall Summary
| Recall Number | Z-1060-2015 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 23, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shape Medical Systems, Inc |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 564 devices |
Product Description
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
Reason for Recall
This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.
Distribution Pattern
Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
Lot / Code Information
Lot Numbers: 1412001, 1412002, 1412003 and 1412004
Other Recalls from Shape Medical Systems, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2051-2014 | Class II | Shape HF Cardiopulmonary System. Made up of S... | May 28, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.